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Randomised, double-blind clinical trial protocol to evaluate whether early and perioperative tranexamic acid administration reduces transfusion rates and blood loss of patients undergoing hip fracture surgery in Spain

Introduction

In patients with a hip fracture, anaemia has been associated with increased transfusion requirements, poor functional outcomes, prolonged hospital stays and increased mortality. While anaemia in elderly patients with hip fractures has traditionally been attributed to bleeding during or after surgery, many of these patients are anaemic on hospital admission. Thus, detecting and managing anaemia in the perioperative, postoperative and, most significantly, the preoperative period is important to avoid the need for blood transfusions and to improve patient outcomes. The protocol for this clinical trial is designed to evaluate the efficacy and safety of both combined intravenous and topical tranexamic acid (TXA) therapy, or topical administration alone, assessing its effect on blood loss and the need for blood transfusions in elderly patients undergoing hip fracture surgery.

Methods and analysis

This is a multicentre, double-blinded, randomised, placebo-controlled trial with a 1:1 allocation ratio. Patients of both sexes, aged ≥65 years, who are admitted to the emergency department and will undergo hip fracture surgery are eligible for enrolment. Eligible patients who provide their consent will be stratified according to the type of fracture (intracapsular and extracapsular) and whether or not they are suitable for intravenous TXA therapy, and they will then be randomly allocated to receive either TXA or a placebo. The primary outcome is the blood transfusion rate from patient admission to the emergency department until discharge, while the secondary outcomes include: the preoperative, perioperative and postoperative haemoglobin and haematocrit levels; the preoperative and postoperative occult and total blood loss; the mean length of hospital stay; and any adverse events assessed for up to 1 year after patient discharge.

Ethics and dissemination

The study was approved by the Basque Country Ethics Committee (Ref.: 2021012) and the Spanish Agency for Medicines and Healthcare Products (Agencia Española de Medicamentos y Productos Sanitarios). All participants will provide their written informed consent prior to study inclusion. The trial’s results, regardless of its outcomes, will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals, and they will be made publicly available through the European Union Clinical Trials Register after the end of the clinical trial.

Trial registration numbers

EudraCT Number 2020-002144-23; EUCT Number 2024-519349-31-00.

Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

Por: Filoteo · J. A. · Maravilla · J. C. · Mamaat · J. E. · Flores · A. D. · Jumamil · A. N. · Cardenas · R. L. · Quijencio · W. · Bayani · M. A. · Santos · N. · Acena · J. L. · Alfonso · A. L. · Rivera · M. · Guarino · R. · Sarmiento · R. · Flenady · V. · Boyle · F. M. · Loughnan · S. A. · T
Objective

This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Design

Cross-sectional survey.

Setting

The Philippines.

Participants

Participants were recruited online and face-to-face from maternal care facilities.

Primary outcome measure

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

Results

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

Conclusions

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

Exploring the correlations of lung ultrasound with delirium and other clinical outcomes in older patients with respiratory failure admitted in acute geriatric units (ECO-AGE): protocol for a multicentre, prospective, observational study from the GRETA Gro

Por: Okoye · C. · Ticinesi · A. · Finazzi · A. · Bruni · A. A. · Guarino · D. · Cerundolo · N. · Nouvenne · A. · Siniscalchi · C. · Meschi · T. · Lauretani · F. · Maggio · M. · Zucchini · I. · Torrini · M. · Cerasuolo · M. · Rizzo · M. R. · Monzani · F. · Antonelli Incalzi · R. · Ungar · A. · B
Introduction

Point-of-care lung ultrasound (LUS) can assist in diagnosing acute respiratory diseases for its high accuracy and immediate availability at the bedside, including older patients with frailty. Delirium represents a frequent complication of hospitalisation in this setting, frequently triggered by acute respiratory diseases. LUS may therefore help identify individuals at risk of delirium, but the association between LUS abnormalities and delirium remains unexplored.

Methods and analysis

This study is a prospective, observational, multicentre study, with the main objective of assessing the correlation between LUS abnormalities and incident delirium during hospitalisation (primary outcome). The secondary objectives are to assess correlations between lung and diaphragm ultrasound parameters and clinical outcomes including duration of delirium, severity of respiratory failure and mortality. 480 patients aged ≥65 years old, urgently hospitalised after an emergency department visit for acute respiratory complaints, will be recruited in eleven acute geriatric wards located in eight teaching hospitals across Italy. LUS examinations will be performed by skilled clinicians prior to treatment whenever feasible, and in any case within 48 hours from admission. They will also undergo comprehensive geriatric assessment, and daily delirium assessment through the 4-AT tool. The association between LUS abnormalities, related parameters (LUS score, Pleural Effusion Score) and outcomes will be assessed by linear and logistic regression models.

Ethics and dissemination

Ethics Committee approval of the coordinating centre (Comitato Etico Territoriale Lombardia 3, reference ID 4369_20.03.2024_M) and collaborative centres has been obtained. All participants will provide written informed consent. Study results will be publicly available following peer-reviewed publication in international scientific journals.

Trial registration number

NCT06670118.

New generation of paediatricians in the health care system: are paediatric residents ready to manage children without supervision? A survey using respiratory infections as a model

Por: Del Bene · M. · Diana · A. · Corsello · A. · Cecere · F. · Indolfi · C. · Mozzillo · E. · Nunziata · F. · Pascarella · F. · Rossi · F. · Sibilio · M. · Ummarino · M. · Guarino · A.
Objectives

To measure the perceived autonomy level in managing lower respiratory tract infections (LRTIs) among paediatric residents and to compare perceived autonomy with the assessments by tutors who directly supervise and evaluate residents

Design/setting

A survey on managing LRTIs was distributed among all Italian paediatric residents and tutors via Google Forms between January 1 and 31, 2024.

Participants, residents and tutors were classified according to their training year and clinical setting: primary care paediatrics (PCP), emergency department (ED) and hospital ward (HW).

Outcome

Perceived autonomy of paediatric residents in managing LRTI in different settings; overall perceived autonomy and interest in employment.

Results

A total of 391 questionnaires were returned, with 273 completed by residents and 118 by tutors. Among residents, 3% in their first year felt fully capable of managing LRTIs without supervision in both ED and HW settings. This percentage remained below 25% until the third year and increased to 72% in ED and 83% in HW by the fifth year. In PCP settings, autonomy ranged from 15% in the first year to 96% in the final year. No differences were found between residents’ self-evaluations and tutors’ assessments. Confidence in skills showed no regional differences across Italy.

Conclusion

Most residents did not feel ready to manage winter respiratory infections in children without supervision, especially in the ED compared with the HW; however, self-confidence was higher in the PCP setting. Tutors shared similar perceptions. The location did not affect the response pattern. These findings caution against employing residents to work autonomously, particularly in emergency settings.

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